Insights+ Key Biosimilars Events of June 2020

 Insights+ Key Biosimilars Events of June 2020

Insights+ Key Biosimilars Events of August 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. Mylan with its partners Lupin and Biocon received MAA for Nepexto (biosimilar, etanercept) in EU and the US FDA’s Approval for Semglee (biosimilar, insulin glargine) respectively. Additionally, Sandoz took an initiative to launch Biosimilars Generation Campaign and received the approval to launch Ziextenzo (biosimilar, pegfilgrastim) and Riximyo (biosimilar, rituximab) in Canada. Our team at PharmaShots has summarized 15 key events of the biosimilar space of June 2020.

1. Mylan and Lupin Received EC’s MAA for Nepexto (biosimilar, etanercept)

       Date: Jun 04, 2020

       Products: Nepexto (biosimilar, etanercept)

  • The EC has granted MAA for Nepexto, a biosimilar referencing Enbrel (etanercept), for all indications of the reference product including RA, JIA, PsA, axSpA (including axSpA and nr-axSpA), plaque psoriasis and pediatric plaque psoriasis
  • The EC’s approval followed the CHMP’s positive opinion which was based on a biosimilarity assessment including preclinical and clinical studies demonstrating bioequivalence to Enbrel
  • The P-III study demonstrated confirmed equivalence of Nepexto to Enbrel in terms of efficacy, safety, and immunogenicity in patients with P-III study with moderate-to-severe active RA. The companies anticipate the launch of Nepexto in H2’20

2. Sandoz Received Health Canada’s Approval to Launch Ziextenzo (biosimilar, pegfilgrastim) and Riximyo (biosimilar, rituximab) in Canada

Date: Jun 10, 2020

 Products: Ziextenzo (biosimilar, pegfilgrastim), Riximyo (biosimilar, rituximab)

  • Health Canada has approved Ziextenzo (a biosimilar referencing Neulasta) and Riximyo (a biosimilar referencing Rituxan) for marketing in Canada
  • Sandoz has received Health Canada’s Notice of Compliance on Apr 21, 2020, for the use of Ziextenzo to reduce the incidence of febrile neutropenia while Riximyo has received approval on Apr 28, 2020, to treat NHL, CLL, and RA
  • The approval of Ziextenzo and Riximyo expands Sandoz’s oncology biosimilar portfolio. The approval reinforces Sandoz’ status as the leading biosimilar and generic pharmaceutical company in Canada  

3. Kyowa Kirin’s FKB327 (biosimilar, adalimumab) Received the MMA Approval in Japan 

Date: Jun 10, 2020

Product: FKB327 (biosimilar, adalimumab)

  • The Kyowa’s FKB327 was the first approved in Japan where Mylan is responsible for its commercialization and has marketed it in 20 countries across EU
  • In 2018, Fujifilm signed an agreement with Mylan to commercialize biosimilar adalimumab in EU and will expand it globally in 2019
  • FKB327 (biosimilar, adalimumab) involves inhibition of Tumor Necrosis Factor (TNF) blocks the inhibition of activity, thereby reducing inflammation and other disease symptoms including RA, plaque psoriasis, Crohn’s disease, and ulcerative colitis

4. Pfizer Received the US FDA’s Approval for its Nyvepria (biosimilar, pegfilgrastim)  

      Date: Jun 11, 2020

      Product: Nyvperia (biosimilar, pegfilgrastim)

  • The US FDA has approved Nyvepria (pegfilgrastim-apgf) to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapies associated with a clinically significant incidence of febrile neutropenia
  • The approval was based on the comprehensive data package and totality of evidence demonstrating a high bio-similarity of Nyvepria to its reference product, Neulasta. The approval provides clinicians with an additional long-acting treatment option that can prevent infections in patients undergoing myelosuppressive CT
  • Following the launch, patients will have access to Pfizer Oncology Together which offers personalized support to patients accessing their prescribed Pfizer Oncology medications. Additionally, the regulatory approval with EMA is under review

5. Celltrion to Evaluate Remsima (biosimilar, infliximab) Against COVID-19 in the UK

Date: Jun 11, 2020

Product: Remsima (biosimilar, infliximab)

  • Celltrion collaborated with the University of Oxford and University Hospitals, Birmingham (UHB) to study the efficacy of Remsima (CT-P13) as a potential treatment for COVID-19
  • UHB will test a series of new drugs in a CATALYST trial. If the CATALYST study indicates benefit CT-P13 it would then be assessed in larger-scale studies in one of the UK national platform trials RECOVERY or REMAP-CAP
  • Additionally, UHB will evaluate Izana Bioscience’s Namilumab (IZN-101) which is a mAb in late-stage studies for RA and ankylosing spondylitis

6. Lannett to Submit Biosimilar Application to the US FDA for its Insulin Glargine by the End of 2022

        Date: Jun 12, 2020

        Product: Insulin Glargine

  • Lannett has provided an update on the clinical advancement of its biosimilar Insulin glargine. Following FDA meeting, Lannett has received FDA’s positive feedback on the clinical and CMC advancement of its biosimilar insulin glargine
  • The company anticipates the filing of 351(k) biosimilar application for its biosimilar insulin glargine candidate by the end of 2022
  • Lannett/HEC’s insulin glargine is a biosimilar to Sanofi’s Lantus (the reference biologic) and met its PK/PD safety endpoints in its study

7. Mylan and Biocon Received the US FDA’s Approval for Semglee (biosimilar, insulin glargine)

        Date: Jun 12, 2020

         Product: Semglee (biosimilar, insulin glargine)

  • The US FDA’s approval was based on comprehensive analytical, preclinical, and clinical programs (including the INSTRIDE (1&2) studies which assessed MYL-1501D (qd) vs Lantus in 558 T1DM & 560 T2DM patients for 52wks. & 24wks. respectively. The 1EPS is changed from baseline in HbA1c after 24 wks.
  • The INSTRIDE demonstrated no difference in safety, efficacy, and immunogenicity of Semglee in comparison to Lantus in T1D & T2D. The drug is approved under the 505(b) NDA pathway and is a deemed a biologic under section 351(a) in accordance with the Biologics Price Competition and Innovation Act in line with other insulin products
  • Semglee has an identical amino acid sequence to Sanofi’s Lantus and is approved in vials and pre-filled pen presentations, to control high blood sugar in adults with T2D and adult and pediatric patients with T1D. Semglee has received regulatory approval in 45+ countries across the world and is the third product approved by the FDA through the Mylan-Biocon biologics collaboration

8. Celltrion Reported Results of Truxima (biosimilar, rituximab) Based Regimen in P-II Study for R/R Aggressive B-cell Lymphoma #EHA25 

       Date: Jun 16, 2020

       Product: Truxima (biosimilar, rituximab)

  • Celltrion has presented the result of P-II study that showed the regimen of Truxima (375mg/m2) + lenalidomide (20mg, day 1-21, qd) + acalabrutinib (100mg, day 1-28, bid) (R2A) is well-tolerated and effective in relapsed/refractory aggressive B-cell lymphoma
  • In the 13 patients who underwent disease assessment following the R2A regimen, ORR (69%) and CR (31%), @6-mos. PFS (83%) and only one patient experienced disease progression after the initial objective response
  • Throughout the study, out of 22 patients, dose reduction was performed in 3 and 1 patients for lenalidomide and acalabrutinib respectively due to hematologic toxicities. The data indicated that the R2A regimen was well tolerated in Korean r/r BCL patients, with initial analysis in non-GCB DLBCL patients showing a promising response

9. Henlius Reported Positive Results of HLX04 (biosimilar, bevacizumab) in P-III Trial for Metastatic Colorectal Cancer

Date: Jun 16, 2020

Product: HLX04 (biosimilar, bevacizumab)

  • The P-III HLX04-mCRC03 trial involved assessing of HLX04 (biosimilar, bevacizumab) or Avastin (bevacizumab) in combination with oxaliplatin and fluoropyrimidine-based CT (XELOX or mFOLFOX6) for 1L patients with mCRC and showed bioequivalent to the Avastin in terms of PK and AEs
  • The product has shown bio-similarity in product quality, pharmacology, PK, PD, toxicology, and immunogenicity in analytical studies, pre-clinical studies and P-I clinical study, Presented at Chinese Society of Clinical Oncology
  • HLX04 is a biosimilar that binds to vascular endothelial growth factor (VEGF) for inhibiting angiogenesis where VEGF acts for promoting the growth of blood vessels can inhibit tumor angiogenesis further preventing tumor growth or metastasis. The biosimilar was developed under Chinese biosimilar guidelines

10. Innovent Received the NMPA’s Approval for Byvasda (biosimilar, bevacizumab) to Treat Non-Small Cell Lung Cancer and Metastatic Colorectal Cancer in China 

 Date: Jun 19, 2020

Products: Byvasda (biosimilar, bevacizumab), TYVYT (sintilimab)

  • The NMPA has approved Byvasda for the treatment of patients with NSCLC and metastatic colorectal cancer. The approval follows TYVYT (sintilimab) approval, indicated to treat patients with Hodgkin’s lymphoma, granted in Dec’2018
  • The launch of Byvasda will provide Chinese patients with high-quality and relatively more affordable bevacizumab biosimilar
  • In Jan’2020, Innovent granted commercial rights of Byvasda in the US and Canada to Coherus BioSciences. Byvasda is a recombinant humanized anti-VEGF mAb targeting VEGF receptors on the surface of vascular endothelial cells, thus inhibiting signalling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK

11. Sandoz Launched the Biosimilars Generation Campaign in Canada

        Date: Jun 26, 2020

        Product: Biosimilars

  • The Biosimilar Generation Campaign provides needed, fact-based, information for patients, and HCPs about biosimilar in Canada. The campaign seeks to increase awareness on the benefits of biosimilars and their safety and efficacy
  • The campaign initiated with the launch of the BiosimilarsGeneration.ca,  which supported plus educate Canadians and provide policy updates from public drug plans along with the information from international research, clinical communities, and patient organizations representing patients living with chronic diseases who take biologic medicines in Canada
  • The Biosimilars Generation reflects the ongoing conversations between various stakeholders across the country, including physicians, patient groups, and caregivers. The campaign provides the opportunity to the healthcare system to realize cost savings 

12. EMA’s CHMP Recommended the Approval of Two Biosimilar Referencing Lilly’s Forsteo (teriparatide) for the Treatment of Osteoporosis  

       Date: Jun 26, 2020

       Products: Livogiva (biosimilar, teriparatide), Qutavina (biosimilar, teriparatide), Forsteo (teriparatide)

  • The CHMP has adopted a positive opinion recommending the approval of Theramex’s Livogiva (biosimilar, teriparatide) intended for the treatment of osteoporosis and will be available as a solution for injection (20 micrograms/80 microliters)
  • The CHMP has also recommended marketing authorization to EuroGenerics’ Qutavina (biosimilar, teriparatide) to treat osteoporosis, also available as a solution for injection (20 micrograms/80 microliters)
  • Both Livogiva and Qutavina are the biosimilar referencing Lilly’s Forsteo (teriparatide) which has received authorization in EU in 2003

13. Samsung Bioepis’ Aybintio (biosimilar, bevacizumab) Received CHMP’s Positive Opinion to Treat Multiple Cancer Indications

 Date: Jun 29, 2020

 Product: Aybintio (biosimilar, bevacizumab)

  • The CHMP has recommended the approval of Aybintio in the EU to treat mCRC, mBC, NSCLC, mRCC, epithelial ovarian, fallopian tube, and primary peritoneal cancer and cervical cancer. The EC will review the CHMP’s positive opinion to grant marketing authorization for the therapy
  • The MAA was based on analytical, PK, clinical data, pharmacology, and toxicology data that demonstrated high bio-similarity with no clinically meaningful differences b/w Aybintio and the reference product, Avastin
  • Aybintio is the Samsung Bioepis’ second oncology biosimilar that receives CHMP’s recommendation for approval. The company has submitted the BLA in Sept’2019 which is currently under the US FDA’s review

14. Samsung Bioepis Reported the Initiation of P-III Study for SB15 Proposed Biosimilar to Eylea (aflibercept)

Date: Jun 29, 2020

Products: SB15 (biosimilar, aflibercept), Eylea (aflibercept)

  • The P-III study compared the efficacy, safety, PK, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration
  • The company has two ophthalmology biosimilar candidates in clinical development, SB11 (ranibizumab) and SB15 (aflibercept). On May 18, 2020, Samsung Bioepis reported 24-week interim results from a P-III study of SB11 (proposed ranibizumab biosimilar)
  • SB15 is a proposed biosimilar referencing Regeneron’s Eylea, currently under preclinical treatment for diabetic macular edema, diabetic retinopathy, retinal edema, and retinal vein occlusion

15. Celltrion’s Remsima SC (biosimilar, infliximab) Received CHMP’s Positive Opinion for an Additional Five Indications Including Inflammatory Bowel Disease and Ankylosing Spondylitis 

      Date: Jun 30, 2020

      Product: Remsima SC (biosimilar, infliximab)

  • CHMP has recommended expanding the existing marketing authorization for Remsima SC for five indications that include AS, CD, UC, PsA, and psoriasis. The CHMP’s positive opinion follows EC’s MAA for the therapy granted in Nov’2019
  • The CHMP’s opinion was based on data evaluating the PK, efficacy, and safety between CT-P13 SC to CT-P13 IV in people with active CD and UC. Part 1 of the study showed overall clinical response as assessed by CDAI-70 with similar scores, clinical remission was high in the SC cohorts with comparable safety profile @54wks.
  • The CHMP has recommended the 120 mg fixed dose of Remsima SC in adults regardless of the body weight, in both existing and newly added indications

Related Post: Insights+ Key Biosimilars Events of May 2020

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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